System and method for connecting devices to a neurostimulator

ABSTRACT

A method for defining connections between a plurality of lead bodies and a plurality of output ports of a neurostimulator, and an external control device for performing the method are disclosed. The external control device includes a user interface and control circuitry. The method includes displaying the lead bodies and the output ports of the neurostimulator; selecting a first one of the lead bodies; dragging a connector from the first lead body to a first one of the output ports of the neurostimulator; and dropping the connector onto the first output port of the neurostimulator, thereby defining a connection between the first lead body and the first output port of the neurostimulator. In another embodiment, a method includes defining the connection between the first lead body and the first output port, and graphically displaying the connection between the first lead body and the first output port of the neurostimulator.

RELATED APPLICATION DATA

The present application is a continuation of U.S. patent applicationSer. No. 13/971,784, filed Aug. 20, 2013, now issued as U.S. Pat. No.______, which claims the benefit under 35 U.S.C. §119 to U.S.Provisional Patent Application Ser. No. 61/694,695, filed Aug. 29, 2012,which are hereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to tissue stimulation systems, and moreparticularly, to a system and method for programming an implantabletissue stimulator.

BACKGROUND OF THE INVENTION

Implantable neurostimulation systems have proven therapeutic in a widevariety of diseases and disorders. Pacemakers and Implantable CardiacDefibrillators (ICDs) have proven highly effective in the treatment of anumber of cardiac conditions (e.g., arrhythmias). Spinal CordStimulation (SCS) systems have long been accepted as a therapeuticmodality for the treatment of chronic pain syndromes, and theapplication of tissue stimulation has begun to expand to additionalapplications such as angina pectoralis and incontinence. Deep BrainStimulation (DBS) has also been applied therapeutically for well over adecade for the treatment of refractory chronic pain syndromes, and DBShas also recently been applied in additional areas such as movementdisorders and epilepsy. Further, in recent investigations PeripheralNerve Stimulation (PNS) systems have demonstrated efficacy in thetreatment of chronic pain syndromes and incontinence, and a number ofadditional applications are currently under investigation. Also,Functional Electrical Stimulation (FES) systems such as the Freehandsystem by NeuroControl (Cleveland, Ohio) have been applied to restoresome functionality to paralyzed extremities in spinal cord injurypatients.

These implantable neurostimulation systems typically include one or moreelectrode carrying neurostimulation leads, which are implanted at thedesired stimulation site, and a neurostimulator (e.g., an implantablepulse generator (IPG)) implanted remotely from the stimulation site, butcoupled either directly to the neurostimulation lead(s) or indirectly tothe neurostimulation lead(s) via a lead extension. Thus, electricalpulses can be delivered from the neurostimulator to the neurostimulationleads to stimulate the tissue and provide the desired efficacioustherapy to the patient. The neurostimulation system may further comprisea handheld patient programmer in the form of a remote control (RC) toremotely instruct the neurostimulator to generate electrical stimulationpulses in accordance with selected stimulation parameters. The RC may,itself, be programmed by a clinician, for example, by using aclinician's programmer (CP), which typically includes a general purposecomputer, such as a laptop, with a programming software packageinstalled thereon.

In the context of a SCS procedure, one or more neurostimulation leadsare introduced through the patient's back into the epidural space, suchthat the electrodes carried by the leads are arranged in a desiredpattern and spacing to create an electrode array. Multi-leadconfigurations have been increasingly used in electrical stimulationapplications (e.g., neurostimulation, cardiac resynchronization therapy,etc.). In the neurostimulation application of SCS, the use of multipleleads increases the stimulation area and penetration depth (thereforecoverage), as well as enables more combinations of anodic and cathodicelectrodes for stimulation, such as transverse multipolar (bipolar,tripolar, or quadra-polar) stimulation, in addition to any longitudinalsingle lead configuration. After proper placement of theneurostimulation leads at the target area of the spinal cord, the leadsare anchored in place at an exit site to prevent movement of theneurostimulation leads. To facilitate the location of theneurostimulator away from the exit point of the neurostimulation leads,lead extensions are sometimes used.

Each lead is then connected, either directly or indirectly through leadextensions, to one or more output ports in the IPG. The IPG can then beoperated to generate electrical pulses that are delivered to the IPGoutput ports, through the leads and/or the lead extensions and conveyedthrough the lead electrodes to the targeted tissue within the spinalcord. If the connection between respective leads and respective outputports in the IPG is not correctly identified in the CP, it is possiblethat the patient will receive little or no benefit from an implanted SCSsystem, or that the programming performed by the CP will be verydifficult and may take an extremely long time. Thus, correctly definingthe connection between the leads and the ports of the IPG can reduceprogramming times, and can mean the difference between effective andineffective pain therapy.

There, thus, remains a need to provide a user interface capable ofallowing a user to easily define the connections between the leads andthe ports of the IPG.

SUMMARY OF THE INVENTION

In accordance with one aspect of the present inventions, an externalcontrol device for selectively defining connections between a pluralityof lead bodies, each coupled to at least one electrode, and a pluralityof output ports of a neurostimulator is provided. The external controldevice includes a user interface configured for receiving input from auser, and for displaying the lead bodies and the output ports of theneurostimulator. The user interface may include a mouse, a trackball, atouchpad, and/or a joystick for receiving the input from the user. Theuser interface may include a digitizer screen for receiving the inputfrom the user.

The external control device also includes control circuitry configuredfor, in response to input from the user, selecting a first one of thelead bodies, dragging a connector from the first lead body to a firstone of the output ports of the neurostimulator, and dropping theconnector onto the first output port of the neurostimulator, therebydefining a connection between the first lead body and the first outputport of the neurostimulator. The user interface may be configured fordisplaying the connection between the first lead body and the firstoutput port of the neurostimulator. The first lead body may include oneof a plurality of tails of a lead. The first lead body may be apercutaneous lead.

The control circuitry may be further configured for verifyingcompatibility between the first lead body and the first output port ofthe neurostimulator. The control circuitry may be configured forselecting the first lead body by coupling a pointing device to the firstlead body, configured for dragging the connector by moving the pointingdevice, and configured for dropping the connector by decoupling thepointing device from the dragged connector. The control circuitry may befurther configured for, in response to additional input from the user,programming the neurostimulator with stimulation parameterscorresponding to the at least one electrode to which the first lead bodyis coupled.

In an optional embodiment, the control circuitry is further configuredfor, in response to input from the user, selecting a second one of thelead bodies, dragging a second connector from the second lead body to asecond one of the output ports of the neurostimulator, and dropping thesecond connector onto the second output port of the neurostimulator,thereby defining a connection between the second lead body and thesecond output port of the neurostimulator.

In accordance with another aspect of the present inventions, a methodfor selectively defining connections between a plurality of lead bodies,each coupled to at least one electrode, and a plurality of output portsof a neurostimulator is provided. The method includes displaying thelead bodies and the output ports of the neurostimulator, and selecting afirst one of the lead bodies. The first lead body may include one of aplurality of tails of a lead. The first lead body may include apercutaneous lead.

The method further includes dragging a connector from the first leadbody to a first one of the output ports of the neurostimulator, anddropping the connector onto the first output port of theneurostimulator, thereby defining a connection between the first leadbody and the first output port of the neurostimulator. The method mayfurther include verifying compatibility between the first lead body andthe first output port of the neurostimulator. The method may furtherinclude programming the neurostimulator with stimulation parameterscorresponding to the at least one electrode to which the first lead bodyis coupled.

In an optional embodiment, the method includes selecting a second one ofthe lead bodies; dragging a second connector from the second lead bodyto a second one of the output ports of the neurostimulator; and droppingthe second connector onto the second output port of the neurostimulator,thereby defining a connection between the second lead body and thesecond output port of the neurostimulator.

In accordance with yet another aspect of the present inventions, anexternal control device for selectively displaying connections between aplurality of lead bodies, each coupled to at least one electrode, and aplurality of output ports of a neurostimulator is provided. The deviceincludes control circuitry configured for, in response to input from auser, defining a connection between a first one of the lead bodies and afirst one of the output ports of the neurostimulator. The first leadbody may include one of a plurality of tails of a lead. The first leadbody may be a percutaneous lead.

The control circuitry may be configured for defining the connectionbetween the first lead body and the first output port of theneurostimulator by, in response to input from the user, selecting thefirst lead body, dragging a connector from the first lead body to thefirst output port of the neurostimulator, and dropping the connectoronto the first output port of the neurostimulator. The control circuitrymay be further configured for verifying compatibility between the firstlead body and the first output port of the neurostimulator. The controlcircuitry may be further configured for, in response to additional inputfrom the user, programming the neurostimulator with stimulationparameters corresponding to the at least one electrode to which thefirst lead body is coupled.

The device also includes a user interface configured for receiving inputfrom the user, and for graphically displaying the lead bodies, theoutput ports of the neurostimulator, and the defined connection betweenthe first lead body and the first output port of the neurostimulator.The user interface may include a mouse, a trackball, a touchpad, and/ora joystick for receiving the input from the user. The user interface mayinclude a digitizer screen for receiving the input from the user.

In an optional embodiment, the control circuitry is further configuredfor, in response to additional input from the user, defining aconnection between a second one of the lead bodies and a second one ofthe output ports of the neurostimulator, and the user interface isfurther configured for graphically displaying the connection between thesecond lead body and the second output port of the neurostimulator.

In accordance with still another embodiment of the present inventions, amethod for selectively displaying connections between a plurality oflead bodies, each coupled to at least one electrode, and a plurality ofoutput ports of a neurostimulator is provided. The method includesgraphically displaying the lead bodies and the output ports of theneurostimulator, and defining a connection between a first one of thelead bodies and a first one of the output ports of the neurostimulator.The first lead body may include one of a plurality of tails of a lead.The first lead body may include a percutaneous lead. Defining theconnection between the first lead body and the first output port of theneurostimulator may include selecting the first lead body; dragging aconnector from the first lead body to the first output port of theneurostimulator; and dropping the connector onto the first output portof the neurostimulator.

The method further includes graphically displaying the definedconnection between the first lead body and the first output port of theneurostimulator. The method may further include verifying compatibilitybetween the first lead body and the first output port of theneurostimulator. The method may further include programming theneurostimulator with stimulation parameters corresponding to the atleast one electrode to which the first lead body is coupled.

In an optional embodiment, the method includes defining a connectionbetween a second one of the lead bodies and a second one of the outputports of the neurostimulator; and graphically displaying the definedconnection between the second lead body and the second output port ofthe neurostimulator.

Other and further aspects and features of the invention will be evidentfrom reading the following detailed description of the preferredembodiments, which are intended to illustrate, not limit, the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of preferred embodimentsof the present invention, in which similar elements are referred to bycommon reference numerals. In order to better appreciate how theabove-recited and other advantages and objects of the present inventionsare obtained, a more particular description of the present inventionsbriefly described above will be rendered by reference to specificembodiments thereof, which are illustrated in the accompanying drawings.Understanding that these drawings depict only typical embodiments of theinvention and are not therefore to be considered limiting of its scope,the invention will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 is plan view of one embodiment of a spinal cord stimulation (SCS)system arranged in accordance with the present inventions;

FIG. 2 a is a plan view of an implantable pulse generator (IPG) and oneembodiment of a surgical paddle stimulation lead used in the SCS systemof FIG. 1;

FIG. 2 b is a plan view of an IPG and one embodiment of a percutaneousstimulation lead used in the SCS system of FIG. 1;

FIG. 2 c is a plan view of an IPG and another embodiment of apercutaneous stimulation lead used in the SCS system of FIG. 1;

FIG. 3 is a plan view of the SCS system of FIG. 1 in use with a patient;

FIG. 4 is a block diagram of the components of a clinician's programmerthat can be used in the SCS system of FIG. 1; and

FIGS. 5 a through 10 b are illustrations of programming screens that canbe displayed by the clinician programmer of FIG. 4, and used to define aconnection between a lead body and an output port of the IPG.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The description that follows relates to a spinal cord stimulation (SCS)system. However, it is to be understood that while the invention lendsitself well to applications in SCS, the invention, in its broadestaspects, may not be so limited. Rather, the invention may be used withany type of implantable electrical circuitry used to stimulate tissue.For example, the present invention may be used as part of a pacemaker, adefibrillator, a cochlear stimulator, a retinal stimulator, a stimulatorconfigured to produce coordinated limb movement, a cortical stimulator,a deep brain stimulator, peripheral nerve stimulator, microstimulator,or in any other neural stimulator configured to treat urinaryincontinence, sleep apnea, shoulder sublaxation, headache, etc.

Turning first to FIG. 1, an exemplary SCS system 10 generally comprisesat least one implantable stimulation lead 12 (e.g., a surgical paddlelead 12(1), multiple percutaneous leads 12(2) having eight electrodes,and/or a percutaneous lead having sixteen electrodes 12(3)), animplantable pulse generator (IPG) 14, an external remote control (RC)16, a Clinician's Programmer (CP) 18, an External Trial Stimulator (ETS)20, and an external charger 22.

The IPG 14 is physically connected via lead extensions 24 to thestimulation lead(s) 12, which carries a plurality of electrodes 26arranged in an array. In the illustrated embodiment, the surgical paddlelead 12(1) carries two columns of electrodes 26, the percutaneous leads12(2) respectively carry two columns of electrodes 26, and thepercutaneous lead 12(3) carries one column of sixteen electrodes 26. Twolead extensions 24 are used to physically connect the IPG 14 to thestimulation lead(s) 12. As will be described in further detail below,the IPG 14 includes pulse generation circuitry that delivers electricalstimulation energy in the form of a pulsed electrical waveform (i.e., atemporal series of electrical pulses) to the electrode array 26 inaccordance with a set of stimulation parameters.

The ETS 20 may also be physically connected via percutaneous leadextensions 28 and/or an external cable 30 to the stimulation lead 12.The ETS 20, which has pulse generation circuitry similar to that of theIPG 14, also delivers electrical stimulation energy in the form of apulse electrical waveform to the electrode array 26 accordance with aset of stimulation parameters. The major difference between the ETS 20and the IPG 14 is that the ETS 20 is a non-implantable device that isused on a trial basis after the stimulation lead 12 has been implantedand prior to implantation of the IPG 14, to test the responsiveness ofthe stimulation that is to be provided. Thus, any functions describedherein with respect to the IPG 14 can likewise be performed with respectto the ETS 20. Further details of an exemplary ETS are described in U.S.Pat. No. 6,895,280, which is expressly incorporated herein by reference.

The RC 16 may be used to telemetrically control the ETS 20 via abi-directional RF communications link 32. Once the IPG 14 andstimulation lead 12 are implanted, the RC 16 may be used totelemetrically control the IPG 14 via a bi-directional RF communicationslink 34. Such control allows the IPG 14 to be turned on or off and to beprogrammed with different stimulation programs after implantation.

The CP 18 provides clinician detailed stimulation parameters forprogramming the IPG 14 and ETS 20 in the operating room and in follow-upsessions. The CP 18 may perform this function by indirectlycommunicating with the IPG 14 or ETS 20, through the RC 16, via an IRcommunications link 36. Alternatively, the CP 18 may directlycommunicate with the IPG 14 or ETS 20 via an RF communications link (notshown).

The external charger 22 is a portable device used to transcutaneouslycharge the IPG 14 via an inductive link 38. For purposes of brevity, thedetails of the external charger 22 will not be described herein. Detailsof exemplary embodiments of external chargers are disclosed in U.S. Pat.No. 6,895,280, which has been previously incorporated herein byreference. Once the IPG 14 has been programmed, and its power source hasbeen charged by the external charger 22 or otherwise replenished, theIPG 14 may function as programmed without the RC 16 or CP 18 beingpresent.

As briefly discussed above, one of the stimulation leads may be asurgical paddle lead 12(1). To this end, and with reference to FIG. 2 a,the surgical paddle lead 12(1) comprises a paddle-shaped membrane 40,and two elongated tails, or lead bodies 42, extending from thepaddle-shaped membrane 40. Each of the lead bodies 42 has a proximal end44 and a distal end 46. Each lead body 42 may, e.g., have a diameterwithin the range of 0.03 inches to 0.07 inches and a length within therange of 30 cm to 90 cm for spinal cord stimulation applications. Eachlead body 42 may be composed of a suitable electrically insulative andbiocompatible material, such as a polymer (e.g., polyurethane orsilicone), and may be extruded as a unibody construction. Thepaddle-shaped membrane 40 is composed of an electrically insulative andbiocompatible material, such as silicone.

The surgical paddle lead 12(1) further comprises proximal contacts 48mounted to the proximal ends 44 of the lead bodies 42 and the pluralityof electrodes 26 mounted on one side of the paddle-shaped membrane 40 ina two-dimensional arrangement. Eight proximal contacts 48 are mounted tothe proximal end 44 of each of the lead bodies 42. The electrodes 26 arein a 2×8 arrangement with two columns having eight electrodes 26 in eachcolumn. Although the stimulation lead 12(1) is shown as having sixteenelectrodes 26 (and thus, sixteen corresponding proximal contacts 48 onthe lead bodies 42), the number of electrodes may be any number suitablefor the application in which the surgical paddle lead 12(1) is intendedto be used.

Instead of two lead bodies 42, the surgical paddle lead 12(1) mayalternatively have three or four lead bodies. For example, a 4×8surgical paddle lead (not shown) comprises four columns of electrodeswith eight electrodes in each column, and four lead bodies. The system10 shown in FIG. 1 may be modified to accommodate a 4×8 surgical paddlelead by adding two more lead extensions 24 and/or two more percutaneousextensions 28 to the system 10. Similarly, if a surgical paddle leadhaving three lead bodies is used in the system 10, three lead extensionswould be needed for the system 10.

Each of the electrodes 26 in the surgical paddle lead 12(1) illustratedin FIG. 2 a takes the form of a disk composed of an electricallyconductive, non-corrosive, material, such as, e.g., platinum, titanium,stainless steel, or alloys thereof. Each of the proximal contacts 48 inthe surgical paddle lead 12(1) illustrated in FIG. 2 a takes the form ofa cylindrical ring element composed of an electrically conductive,biocompatible, non-corrosive, material, such as, e.g., platinum,titanium, stainless steel, or alloys thereof.

The surgical paddle lead 12(1) also includes a plurality of electricalconductors (not shown) extending through individual lumens (not shown)within each lead body 42 and connected between the respective proximalcontacts 48 and electrodes 26 using suitable means, such as welding.Further details regarding the construction and method of manufacture ofsurgical paddle leads are disclosed in U.S. Patent ApplicationPublication No. 2007/0150036, entitled “Stimulator Leads and Methods forLead Fabrication,” the disclosure of which is expressly incorporatedherein by reference.

As briefly discussed above, instead of a surgical paddle lead 12(1), twopercutaneous leads 12(2) having eight electrodes 26 each may be used. Tothis end, and with reference to FIG. 2 b, each percutaneous lead 12(2)comprises an elongated lead body 42 having a proximal end 44 and adistal end 46. Each lead body 42 may, e.g., have a diameter within therange of 0.03 inches to 0.07 inches and a length within the range of 30cm to 90 cm for spinal cord stimulation applications. The lead body 42may be composed of a suitable electrically insulative and biocompatiblematerial, such as, a polymer (e.g., polyurethane or silicone), and maybe extruded as a unibody construction.

Each percutaneous lead 12(2) further comprises a plurality of proximalcontacts 48 mounted to the proximal end 44 of the lead body 42 and theplurality of in-line electrodes 26 mounted to the distal end 46 of thelead body 42. Although each of the percutaneous leads 12(2) is shown ashaving eight electrodes 26 (and thus, eight corresponding proximalcontacts 48), the number of electrodes may be any number suitable forthe application in which the percutaneous lead 12(2) is intended to beused (e.g., one, two, four, sixteen, etc.). Similarly, although thesystem 10 is depicted as accommodating four percutaneous leads, thenumber of leads may be any number suitable for the application in whichthe system 10 is intended to be used.

As briefly discussed above, a percutaneous lead 12(3) having sixteenelectrodes 26 and two tails, or lead bodies 42, as shown in FIG. 2 c maybe used in the system 10. Each of the lead bodies 42 includes eightproximal contacts 48 mounted to the proximal end thereof. The proximalcontacts 48 on one of the lead bodies 42 correspond to the distal set ofeight electrodes on the lead 12(2), and the proximal contacts 48 on theother lead body 42 correspond to the proximal set of eight electrodes.

Each of the electrodes 26 and proximal contacts 48 in the percutaneousleads 12(2) and 12(3) illustrated in FIGS. 2 b and 2 c takes the form ofa cylindrical ring element composed of an electrically conductive,biocompatible, non-corrosive, material, such as, e.g., platinum,titanium, stainless steel, or alloys thereof, which is circumferentiallydisposed about the lead bodies 42.

Each percutaneous lead 12(2) and 12(3) also includes a plurality ofelectrical conductors (not shown) extending within the lead body 42 andconnected between the respective proximal contacts 48 and electrodes 26using suitable means, such as welding. Further details describing theconstruction and method of manufacturing percutaneous stimulation leadsare disclosed in U.S. Patent Application Publication No. 2007/0168007,entitled “Lead Assembly and Method of Making Same,” and U.S. PatentApplication Publication No. 2007/0168004, entitled “CylindricalMulti-Contact Electrode Lead for Neural Stimulation and Method of MakingSame,” the disclosures of which are expressly incorporated herein byreference.

Referring to any of FIG. 2 a, 2 b, or 2 c, the IPG 14 comprises an outercase 50 housing the electronic and other components (described infurther detail below). The outer case 50 is composed of an electricallyconductive, biocompatible material, such as titanium, and forms ahermetically sealed compartment wherein the internal electronics areprotected from the body tissue and fluids. In some cases, the outer case50 serves as an electrode. The IPG 14 further comprises a connector 52in which the proximal ends 44 of the lead bodies 42 of the stimulationleads 12 can mate in a manner that electrically couples the electrodes26 to the electronics contained within the outer case 50. To this end,the connector 52 includes a four ports 54 (only one shown in phantom)for receiving the proximal ends 44 of the two lead bodies 42 of thesurgical paddle lead 12(1), or the proximal ends 44 of the two bodies 42of the respective percutaneous leads 12(2), or the proximal ends 44 ofthe two lead bodies of the percutaneous lead 12(3). In the case wherethe lead extensions 24 are used, the ports 54 may instead receive theproximal ends of such lead extensions 24.

It should be noted that, although the lead bodies of the surgical paddlelead 12(1) or the percutaneous leads 12(2) or 12(3) will be describedhereinafter as being mated with the ports 54, lead extensions, adaptors,and/or splitters can be considered to be lead bodies when mated with therespective surgical paddle lead or percutaneous leads. Thus, for thepurposes of this specification, a “lead body” is simply an elongatedmember with proximal contacts that can be mated to a port of aneurostimulator to allow the electrodes on the surgical paddle lead orpercutaneous lead to be electrically coupled to the circuitry containedwithin the neurostimulator. The significance for the present inventionsis that the connection between each of the lead bodies (which mayinclude a lead extension, adaptor, and/or splitter) and the port 54 inthe IPG 14 can be defined in the CP 18 so that the CP 18 can properlyprogram the IPG 14 to provide the correct stimulation parameters to thecorrect electrodes at the distal ends of the lead bodies.

As will be described in further detail below, the IPG 14 includes pulsegeneration circuitry that provides electrical stimulation energy to theelectrodes 26 in accordance with a set of parameters. Such parametersmay comprise electrode combinations, which define the electrodes thatare activated as anodes (positive), cathodes (negative), and turned off(zero), and electrical pulse parameters, which define the pulseamplitude (measured in milliamps or volts depending on whether the IPG14 supplies constant current or constant voltage to the electrodes),pulse duration (measured in microseconds), pulse rate (measured inpulses per second), and pulse shape.

With respect to the pulse patterns provided during operation of the SCSsystem 10, electrodes that are selected to transmit or receiveelectrical energy are referred to herein as “activated,” whileelectrodes that are not selected to transmit or receive electricalenergy are referred to herein as “non-activated.” Electrical energydelivery will occur between two (or more) electrodes, one of which maybe the IPG case 50, so that the electrical current has a path from theenergy source contained within the IPG case 50 to the tissue and a sinkpath from the tissue to the energy source contained within the case.Electrical energy may be transmitted to the tissue in a monopolar ormultipolar (e.g., bipolar, tripolar, etc.) fashion.

Monopolar delivery occurs when a selected one or more of the leadelectrodes 26 is activated along with the case 50 of the IPG 14, so thatelectrical energy is transmitted between the selected electrode 26 andcase 50. Monopolar delivery may also occur when one or more of the leadelectrodes 26 are activated along with a large group of lead electrodeslocated remotely from the one or more lead electrodes 26 so as to createa monopolar effect; that is, electrical energy is conveyed from the oneor more lead electrodes 26 in a relatively isotropic manner. Bipolardelivery occurs when two of the lead electrodes 26 are activated asanode and cathode, so that electrical energy is transmitted between theselected electrodes 26. Tripolar delivery occurs when three of the leadelectrodes 26 are activated, two as anodes and the remaining one as acathode, or two as cathodes and the remaining one as an anode.

Referring to FIG. 3, the stimulation lead 12 (either 12(1), 12(2), or12(3)) is implanted within the spinal column 56 of a patient 58. Thepreferred placement of the electrode leads 12 is adjacent, i.e., restingnear, or upon the dura, adjacent to the spinal cord area to bestimulated. While the electrode lead 12 is illustrated as beingimplanted near the spinal cord area of a patient, the electrodes lead 12may be implanted anywhere in the patient's body, including a peripheralregion, such as a limb, or the brain. Due to the lack of space near thelocation where the electrode lead 12 exits the spinal column 56, the IPG14 is generally implanted in a surgically-made pocket either in theabdomen or above the buttocks. The IPG 14 may, of course, also beimplanted in other locations of the patient's body. The lead extensions24 facilitate locating the IPG 14 away from the exit point of theelectrode lead 12. As there shown, the CP 18 communicates with the IPG14 via the RC 16.

As briefly discussed above, the CP 18 greatly simplifies the programmingof multiple electrode combinations, allowing the user (e.g., thephysician or clinician) to readily determine the desired stimulationparameters to be programmed into the IPG 14, as well as the RC 16. Thus,modification of the stimulation parameters in the programmable memory ofthe IPG 14 after implantation is performed by a user using the CP 18,which can directly communicate with the IPG 14 or indirectly communicatewith the IPG 14 via the RC 16. That is, the CP 18 can be used by theuser to modify operating parameters of the electrode array 26 near thespinal cord.

As shown in FIG. 3, the overall appearance of the CP 18 is that of alaptop personal computer (PC), and in fact, may be implemented using aPC that has been appropriately configured to include adirectional-programming device and programmed to perform the functionsdescribed herein. Thus, the programming methodologies can be performedby executing software instructions contained within the CP 18.Alternatively, such programming methodologies can be performed usingfirmware or hardware. In any event, the CP 18 may actively control thecharacteristics of the electrical stimulation generated by the IPG 14 toallow the optimum stimulation parameters to be determined based onpatient feedback and may subsequently program the IPG 14 with theoptimum stimulation parameters.

To allow the clinician to perform these functions, the CP 18 includes auser interface. In the illustrated embodiment, the user interface of theCP 18 includes a mouse 121, a keyboard 122, and a programming displayscreen 124 housed in a case 126. It is to be understood that in additionto, or in lieu of, the mouse 121, other directional programming devicesmay be used, such as a trackball, touchpad, joystick, or directionalkeys included as part of the keys associated with the keyboard 122.

In the illustrated embodiment described below, the display screen 124takes the form of a conventional screen, in which case, a virtualpointing device, such as a cursor controlled by a mouse, joy stick,trackball, etc, can be used to manipulate graphical objects on thedisplay screen 124. In alternative embodiments, the display screen 124takes the form of a digitizer touch screen, which may be either passiveor active. If passive, the display screen 124 includes detectioncircuitry that recognizes pressure or a change in an electrical currentwhen a passive device, such as a finger or non-electronic stylus,contacts the screen. If active, the display screen 124 includesdetection circuitry that recognizes a signal transmitted by anelectronic pen or stylus. In either case, detection circuitry is capableof detecting when a physical pointing device (e.g., a finger, anon-electronic stylus, or an electronic stylus) is in close proximity tothe screen 124, whether it be making physical contact between thepointing device and the screen or bringing the pointing device inproximity to the screen within a predetermined distance, as well asdetecting the location of the screen in which the physical pointingdevice is in close proximity. When the pointing device touches orotherwise is in close proximity to the screen, the graphical object onthe screen adjacent to the touch point is “locked” for manipulation, andwhen the pointing device is moved away from the screen the previouslylocked object is unlocked.

As shown in FIG. 4, the CP 18 generally includes control circuitry 128(e.g., a central processor unit (CPU)) and memory 130 that stores astimulation programming package 132, which can be executed by thecontrol circuitry 128 to allow a clinician to program the IPG 14 and RC16. The control circuitry 128 is in communication with a user inputdevice, which in the illustrated embodiment includes the mouse 121 andthe keyboard 122, but may, as discussed above, alternatively oradditionally include other devices. The CP 18 further includes telemetrycircuitry 134 for downloading stimulation parameters to the RC 16 anduploading stimulation parameters already stored in the memory of the RC16 via link 36 (shown in FIG. 1). The telemetry circuitry 134 is alsoconfigured for transmitting the control data (including stimulationparameters and requests to provide status information) to the IPG 14 andreceiving status information (including the measured electrical data)from the IPG 14 indirectly via the RC 16.

Execution of the programming package 132 by the control circuitry 128provides a multitude of display screens (not shown) that can benavigated through via use of the mouse 121. These display screens allowthe clinician to, among other functions, select or enter patient profileinformation (e.g., name, birth date, patient identification, physician,diagnosis, and address), enter procedure information (e.g.,programming/follow-up, implant trial system, implant IPG, implant IPGand lead(s), replace IPG, replace IPG and leads, replace or reviseleads, explant, etc.), generate a pain map of the patient, define theconfiguration and orientation of the leads, initiate and control theelectrical stimulation energy output by the neurostimulation leads 12,and select and program the IPG 14 with stimulation parameters in both asurgical setting and a clinical setting. Further details discussing theabove-described CP functions are disclosed in U.S. Patent ApplicationPublication No. 2010/0010566, entitled “System and Method for ConvertingTissue Stimulation Programs in a Format Usable by an Electrical CurrentSteering Navigator,” and U.S. Patent Application Publication No.2010/0121409, entitled “System and Method for Determining AppropriateSteering Tables for Distributing Stimulation Energy Among MultipleNeurostimulation Electrodes,” which are expressly incorporated herein byreference.

Most pertinent to the present inventions, programming of the IPG 14 canbe performed based on a user-defined connection between a lead body andan output port of the IPG corresponding to the actual physicalconnection between the lead body 42 and the output port 54 of the IPG14. This connection is graphically displayed along with a graphicaldepiction of the lead body and a graphical depiction of a plurality ofoutput ports of the IPG.

The connection may be defined using the programming screen 140 shown inFIGS. 5 a-7 b. Before the connection is defined, the programming screen140 displays lead bodies 142, connectors 143 at the ends of the leadbodies 142, and a plurality of output ports 154 of the IPG. The leadbodies 142 may be graphically displayed in the context of an anatomicalregion, and in this case, the spinal column 156 of the patient. The leadbodies 142 shown in FIG. 5 a are tails of a surgical paddle lead 112(1),the lead bodies 142 shown in FIG. 6 a are percutaneous leads 112(2), andthe lead bodies 142 shown in FIG. 7 a are tails of a percutaneous lead112(3). Although the screen 140 is shown displaying two lead bodies, thenumber of lead bodies displayed may be any number corresponding to thenumber of lead bodies that are implanted within the patient.

The connection between one of the lead bodies 142 and one of the outputports 154 is defined by first selecting the lead body 142. If the leadbody 142 is one of the tails of a surgical paddle lead 112(1) as shownin FIG. 5 a, then the lead body 142 is selected by selecting one of theplurality of tails of the surgical paddle lead 112(1). If the lead body142 is a percutaneous lead 112(2), as shown in FIG. 6 a, then the leadbody 142 is selected by selecting the percutaneous lead 112(2). If thelead body 142 is one the tails of a percutaneous lead 112(3), as shownin FIG. 7 a, then the lead body 142 is selected by selecting one of theplurality of tails. When the lead body 142 is selected, a lead bodyconnector 143 appears. Alternatively, rather than selecting the leadbody, the lead body connector 143 may be selected. The lead bodyconnector 143 is capable of being displaced relative to the lead body142. After selecting the lead body 142, the connector 143 is draggedfrom the lead body 142 to one of the output ports 154, and then droppedonto the output port 154. The control circuitry is configured forverifying compatibility between the lead body 142 and the output port154 of the IPG. The procedure is then repeated for defining a connectionbetween the other lead body 142 and another output port 154 of the IPG.If compatibility is verified, then the defined connections 146 aredisplayed as shown in FIGS. 5 b, 6 b, and 7 b. The defined connections146 are then used during programming the IPG 14 so that the stimulationis directed to the correct electrodes.

The manner in which the lead body 142 is selected, and the lead bodyconnector 143 is dragged and dropped will depend on the nature of theuser interface. For example, if the display screen 124 is conventional,and a mouse 121 is used to control a pointing device, such as a cursor,the user may couple the cursor to the lead body 142 by, e.g., placingthe cursor adjacent to the lead body 142 and clicking and holding on theappropriate button of the mouse 121, thereby selecting the lead body142. The user can then move the cursor to displace the lead bodyconnector 143 within the programming screen 140, thereby dragging thelead body connector 143 towards the selected IPG output port 154. Oncethe lead body connector 143 is within the selected IPG output port 154,the user can release the button of the mouse 121 to decouple the cursorfrom the lead body connector 143, thereby dropping the lead bodyconnector within the selected IPG output port 154.

As another example, if the display screen 124 is a digitizer screen, anda stylus or finger is used as the pointing device, the user may couplethe stylus/finger to the lead body 142 by, e.g., placing thestylus/finger adjacent to the lead body 142 and physically touching theprogramming screen, thereby selecting the lead body 142. The user canthen move the stylus/finger across the programming screen 140 todisplace a lead body connector 143 within the screen, thereby draggingthe lead body connector 143 toward the selected IPG output port 154.Once the lead body connector 143 is within the selected IPG output port154, the user can remove the stylus/finger from the programming screen140 to decouple the stylus/finger from the lead body connector 143,thereby dropping the lead body connector 143 into the IPG output port154.

As briefly mentioned above, the connection between a lead and an outputport of the IPG may include lead extensions, adaptors, and/or splitters.FIGS. 8 a-10 b depict exemplary programming screens 140 for defining aconnection between a lead and an output port that includes an adaptor ora splitter.

FIG. 8 a depicts a lead 112(4) having eight electrodes and two tails, orlead bodies 142. Each lead body 142 includes a connector 143 coupled tofour of the electrodes. An adaptor 160 is depicted in FIG. 8 a as beingdisposed between the lead bodies 142 and the output ports 154 of theIPG. The side of the adaptor 160 facing the lead bodies 142 includes twodistal connectors 162 configured for being coupled to the lead bodyconnectors 143. The side of the adaptor 160 facing the output ports 154of the IPG includes one proximal connector 164 configured for beingcoupled to one of the output ports 154 of the IPG. In this manner, theadaptor 160 is configured for coupling both of the lead bodies 142 to asingle one of the output ports 154. In a method for defining theconnection between the lead bodies 142 and one of the output ports 154,one of the lead bodies 142 is selected and the lead body connector 143of the selected lead body is dragged and dropped onto one of the distalconnectors 162 of the adaptor 160. Similarly, the other lead body 142 isselected and the lead body connector 143 of the selected lead body isdragged and dropped onto the other one of the distal connectors 162 ofthe adaptor 160. Thus, connections 166 between the lead bodies 142 andthe adaptor 160 are defined, as shown in FIG. 8 b. The proximalconnector 164 of the adaptor 160 is selected, dragged, and dropped ontoone of the output ports 154 of the IPG, thereby defining a connection168 between the adaptor 160 and the output port 154. Thus, theconnection between the lead bodies 142 and the output port 154 of theIPG includes connections 166 and 168.

The lead bodies 142 in FIG. 9 a are percutaneous leads 112(5) eachhaving four electrodes. Each of the lead bodies 142 includes a lead bodyconnector 143. An adaptor 160 is depicted in FIG. 9 a as being disposedbetween the lead bodies 142 and the output ports 154 of the IPG. Theside of the adaptor 160 facing the lead bodies 142 includes two distalconnectors 162 configured for being coupled to the lead body connectors143. The side of the adaptor 160 facing the output ports 154 of the IPGincludes one proximal connector 164 configured for being coupled to oneof the output ports 154 of the IPG. In this manner, the adaptor 160 isconfigured for coupling both of the lead bodies 142 to a single one ofthe output ports 154. In a method for defining the connection betweenthe lead bodies 142 and one of the output ports 154, one of the leadbodies 142 is selected and the lead body connector 143 of the selectedlead body is dragged and dropped onto one of the distal connectors 162of the adaptor 160. Similarly, the other lead body 142 is selected andthe lead body connector 143 of the selected lead body is dragged anddropped onto the other one of the distal connectors 162 of the adaptor160. Thus, connections 166 between the lead bodies 142 and the adaptor160 are defined, as shown in FIG. 9 b. The proximal connector 164 of theadaptor 160 is selected, dragged, and dropped onto one of the outputports 154 of the IPG, thereby defining a connection 168 between theadaptor 160 and the output port 154. Thus, the connection between thelead bodies 142 and the output port 154 of the IPG includes connections166 and 168.

The lead body 142 in FIG. 10 a is a percutaneous lead 112(6) havingsixteen electrodes, all of which are coupled to the connector 143. Asplitter 170 is depicted in FIG. 10 a as being disposed between the leadbody 142 and the output ports 154 of the IPG. The side of the splitter170 facing the lead body 142 includes a distal connector 172 configuredfor being coupled to the lead body connector 143. The side of thesplitter 170 facing the output ports 154 of the IPG includes twoproximal connectors 174, each configured for being coupled to one of theoutput ports 154 of the IPG. In this manner, the splitter 170 isconfigured for coupling the lead body 142 to two of the output ports154. In a method for defining the connection between the lead body 142and the output ports 154, the lead body 142 is selected and the leadbody connector 143 is dragged and dropped onto the distal connector 172of the splitter 170, thereby defining a connection 176 between the leadbody 142 and the splitter 170, as shown in FIG. 10 b. One of theproximal connectors 174 of the splitter 170 is selected, dragged, anddropped onto one of the output ports 154 of the IPG. Similarly, theother proximal connection 174 of the splitter 170 is selected, dragged,and dropped onto another one of the output ports 154 of the IPG. Thus,connections 178 between the splitter 170 and the output ports 154 aredefined. The connection between the lead body 142 and the output ports154 of the IPG includes connections 176 and 178.

Although the foregoing technique has been described as being implementedin the CP 18, it should be noted that this technique may bealternatively or additionally implemented in the RC 16. Furthermore,although particular embodiments of the present inventions have beenshown and described, it will be understood that it is not intended tolimit the present inventions to the preferred embodiments, and it willbe obvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present inventions. Thus, the present inventions are intended tocover alternatives, modifications, and equivalents, which may beincluded within the spirit and scope of the present inventions asdefined by the claims.

1.-16. (canceled)
 17. An external control device for selectivelydisplaying connections between a plurality of lead bodies, each coupledto at least one electrode, and a plurality of output ports of aneurostimulator, the external control device comprising: controlcircuitry configured for, in response to input from a user, defining aconnection between a first one of the lead bodies and a first one of theoutput ports of the neurostimulator; and a user interface configured forreceiving input from the user, and for graphically displaying the leadbodies, the output ports of the neurostimulator, and the definedconnection between the first lead body and the first output port of theneurostimulator.
 18. The external control device of claim 17, whereinthe control circuitry is configured for defining the connection betweenthe first lead body and the first output port of the neurostimulator by,in response to input from the user, selecting the first lead body,dragging a connector from the first lead body to the first output portof the neurostimulator, and dropping the connector onto the first outputport of the neurostimulator.
 19. The external control device of claim17, wherein the control circuitry is further configured for, in responseto additional input from the user, defining a connection between asecond one of the lead bodies and a second one of the output ports ofthe neurostimulator, and wherein the user interface is furtherconfigured for graphically displaying the connection between the secondlead body and the second output port of the neurostimulator.
 20. Theexternal control device of claim 17, wherein the control circuitry isfurther configured for verifying compatibility between the first leadbody and the first output port of the neurostimulator.
 21. The externalcontrol device of claim 17, wherein the user interface comprises one ormore of a mouse, a trackball, a touchpad, and a joystick for receivingthe input from the user.
 22. The external control device of claim 17,wherein the user interface comprises a digitizer screen for receivingthe input from the user.
 23. The external control device of claim 17,wherein the control circuitry is further configured for, in response toadditional input from the user, programming the neurostimulator withstimulation parameters corresponding to the at least one electrode towhich the first lead body is coupled.
 24. The external control device ofclaim 17, wherein the first lead body comprises one of a plurality oftails of a lead.
 25. The external control device of claim 17, whereinthe first lead body is a percutaneous lead.
 26. A method for selectivelydisplaying connections between a plurality of lead bodies, each coupledto at least one electrode, and a plurality of output ports of aneurostimulator, the method comprising: graphically displaying the leadbodies and the output ports of the neurostimulator; defining aconnection between a first one of the lead bodies and a first one of theoutput ports of the neurostimulator; and graphically displaying thedefined connection between the first lead body and the first output portof the neurostimulator.
 27. The method of claim 26, wherein defining theconnection between the first lead body and the first output port of theneurostimulator comprises: selecting the first lead body; dragging aconnector from the first lead body to the first output port of theneurostimulator; and dropping the connector onto the first output portof the neurostimulator.
 28. The method of claim 26, further comprisingverifying compatibility between the first lead body and the first outputport of the neurostimulator.
 29. The method of claim 26, furthercomprising: defining a connection between a second one of the leadbodies and a second one of the output ports of the neurostimulator; andgraphically displaying the defined connection between the second leadbody and the second output port of the neurostimulator.
 30. The methodof claim 26, further comprising programming the neurostimulator withstimulation parameters corresponding to the at least one electrode towhich the first lead body is coupled.
 31. The method of claim 26,wherein the first lead body comprises one of a plurality of tails of alead.
 32. The method of claim 26, wherein the first lead body comprisesa percutaneous lead.